for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. On November 12, 2024, the FDA granted the ...

The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...

The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

The path from a scientist’s initial idea to a new medicine that can save lives is a complex and often lengthy process. It ...

Excitement is building around a new weight loss drug, CagriSema, which is expected to surpass the effects of popular drugs ...

AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...

Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

Google DeepMind releases AlphaFold 3's source code to academics, marking a significant advance in AI-powered molecular biology and drug discovery, while balancing open science with commercial ...

FDA sets PDUFA Action Date of June 28, 2025 ...

Using that new knowledge, they developed a new drug that may counteract the interference and boost the effectiveness ... and ...